Diced Cartilage in Breast Reconstruction

NCT06504173 | Completed

• 1 other identifier: DIC-RIP
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 2

Brief Summary

Exposure of internal mammary vessels in autologous breast reconstruction often requires removal of a rib cartilage segment, which can lead to contour deformity in the craniomedial breast pole. This study evaluated the use of diced cartilage (DC) to counteract substance loss in the microvascular anastomosis area, and investigated safety and suitability of the procedure to avoid postoperative deformities.

Conditions

Mammaplasty; Microsurgery; Rip Reconstruction Cartilage

Outcome Measures

Primary Outcomes (1)

• Magnetic resonance imaging (MRI) scans: soft tissue sinking of the recipient vessels area

  the sinking depth of epicostal soft tissue into the space of rib segment resection on axial planes in Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

  October 2021 to June 2023

Secondary Outcomes (1)

• Visual contour deficit of the recipient vessels area

  October 2021 to June 2023

Study Arms (2)

diced cartilage (DC)

After removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was restored with diced cartilage (DC) out of the removed rip cartialge.

Procedure: diced cartilage

control

After removing a part of the rip cartilage and microsurgery, the exposed internal mammary vessels in autologous free flap breast reconstruction was NOT restored.

Interventions

diced cartilage PROCEDURE

In reconstructions using DC management of IMVES, the surgical nurse processed the removed cartilage into DC using a dermatome blade. Cartilage pieces of approximately 0,5-1 mm were used. After microvascular anastomosis (coupler device for venous anastomosis; Synovis MCA, Birmingham AL, USA), all DC was placed back into the rib removal zone using a blunt dissector. The vessels were embedded and stabilized in cartilage paste according to the desired orientation.

diced cartilage (DC)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: The limitation of this study to the female gender is due to the phenotypic anatomical body structure and the intended reconstruction.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of women who received autologous free flap breast reconstruction using internal mammary vessels as recipient vessels.

You may qualify if:

• Autologous free flap breast reconstruction using the internal mammary vessels as recipient vessels from October 2021 to June 2023
• MRI subcohort: Magnetic resonance imaging (MRI) scans performed at least 6 months postoperatively

You may not qualify if:

• Autologous free flap breast reconstruction using a perforator of the internal mammary vessels as recipient vessels from October 2021 to June 2023
• Autologous free flap breast reconstruction using the thoracodorsal vessels as recipient vessels from October 2021 to June 2023

Sponsors & Collaborators

• ISAR Klinikum: lead
• Breast Imaging Division, Radiologie Augsburg Friedberg / Breast Center Augsburg, Augsburg, Germany: collaborator

Study Sites (2)

ISAR Klinikum - Department Plastic Surgery

Munich, Bavaria, 80331, Germany

Location

ISAR Klinikum

Munich, Bavaria, 80331, Germany

Location

Study Officials

• Ulf Dornseifer, MD/PhD

  Head of Department plastic and reconstructive surgery ISAR Klinikum

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)